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2020 ISPE Annual Meeting & Expo


NA20CENOV1/SES218 - Drug Shortages: Progress in a Challenging Year


Nov 5, 2020 9:30am ‐ Nov 5, 2020 11:00am

Expiration Date: Nov 30, 2021

Description

Drug Shortages: Progress in a Challenging Year | Following the issuance of the FDA Drug Shortage Report: The Root Causes and Potential Solutions, industry and outside stakeholders have gained renewed interest in proactively assessing vulnerabilities and reducing their risks of drug shortages, particularly during the global constraints and surge in demand for medicines during the COVID 19 pandemic. In this session, experts from the pharmaceutical industry and regulators will present lessons learned and experiences, and the key role of early communication with health authorities (HA).

The Outputs from the ISPE Drug Shortages session will include:
- An example of Business Continuity Management at a global pharmaceutical company which can help avoid or at least respond to potential drug shortages.
- Industry best practices for early detection and notification mechanism of situations that could lead to drug shortages.
- FDA's role and experience with working with industry to prevent and mitigate drug shortages.

As a result of this session participants will gain:
- Points to consider for the establishment of an effective companywide Business Continuity Plan.
- Approaches and tools to apply for early detection and communication of Drug Shortages.
- Industry best practice on how best to engage and communication with HAs.
- Opportunities to interact with FDA, Industry and Academic experts in a Q&A session.

Session Leader(s):

Speaker(s):

  • Guy Stone, BCM & NEM Manager, Advanced Accelerator Applications (a Novartis Company)
  • Nasir Egal, Vice President, Global Quality, Sanofi
  • Jeannie C. David, Senior Program Management Officer, Drug Shortages Staff, CDER/FDA
  • Diane L. Hustead, Director, Regulatory Affairs, Merck & Co., Inc.

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